BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS LIAT SYSTEM

    MDR report key: 12426305 · Received September 4, 2021

    Report

    Report Number
    2243471-2021-03200
    Event Type
    Malfunction
    Date Received
    September 4, 2021
    Date of Event
    August 4, 2021
    Report Date
    September 4, 2021
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    2243471-03-17-2021-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ROCHE RECEIVED COMPLAINTS ALLEGING INVALID AND/OR FALSE POSITIVE RESULTS WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM FOR ONE OR MORE TARGETS (SARS-COV-2, INFLUENZA A, INFLUENZA B). WHEN REVIEWING THE CUSTOMER-PROVIDED DATA ASSOCIATED WITH THE REPORTED INVALID AND FALSE POSITIVE RESULTS, ABNORMAL PCR CURVES WERE OBSERVED. PER THE ON-GOING INVESTIGATION, SEVERAL POTENTIAL CAUSES FOR THE ABNORMAL PCR GROWTH CURVES LEADING TO INVALIDS AND FALSE POSITIVES HAVE BEEN IDENTIFIED. THESE INCLUDE TUBE LEAKS, ABNORMAL PCR STEPS, AND LOOSE THERMAL SENSOR WIRING. OVERALL ACROSS THE INSTALLED BASE, THESE ISSUES FROM PRODUCT USE MAY OCCUR SPORADICALLY. FOR INVALID OR FALSE POSITIVE INFLUENZA RESULTS, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY. FOR INVALID SARS-COV-2, ADVERSE HEALTH CONSEQUENCES ARE NOT LIKELY SINCE DETECTABILITY IS HIGH AND TESTING CAN BE PERFORMED ON ALTERNATIVE PLATFORMS. FOR ERRONEOUS POSITIVE SARS-COV-2 RESULTS, THERE IS THE POSSIBILITY OF ADVERSE HEALTH CONSEQUENCES IN HIGH RISK INDIVIDUALS. AS STATED IN THE INSTRUCTIONS FOR USE, CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. A COBAS LIAT SOFTWARE UPDATE TO BETTER IDENTIFY THE THERMAL SENSOR ERRORS AND A NEW COBAS® SARS-COV-2 & INFLUENZA A/B SCRIPT TO BETTER DETECT ABNORMAL PCR CURVES HAVE BEEN LAUNCHED. THE IMPLEMENTATION OF BOTH THE SOFTWARE AND THE UPDATED SCRIPT HAVE SHOWN A REDUCTION IN THE CALCULATED FALSE POSITIVE RATE. CONSIGNEES HAVE BEEN NOTIFIED. (B)(4).

    Description of Event or Problem · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTIC TESTS, THE AGENCY HAS REQUESTED HEIGHTENED REPORTING BEYOND THE REASONABLY SUGGESTS REQUIREMENTS OF 803 TO INCLUDE ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE. PURSUANT TO THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. THE CUSTOMER ALLEGED DISCREPANT RESULTS GENERATED FOR THE COBAS® SARS-COV-2 & INFLUENZA A/B (SCFA) ASSAY. A CUSTOMER FROM THE UNITED STATES ALLEGED THAT THEY RECEIVED 13 POTENTIAL FALSE POSITIVE RESULTS WHEN TESTED WITH THE COBAS® SARS-COV-2 & INFLUENZA A/B (SCFA) ASSAY. A REVIEW OF THE COBAS® LIAT® SYSTEM (S/N (B)(4)) DATA SET IDENTIFIED THAT RUNS #707, 725, 732, 737, 792, 800, 812, 816, 817, 889, 920, 930 AND 931 ALL GENERATED INFLUENZA B POSITIVE RESULTS. THE PATIENTS¿ SAME SAMPLES WERE REPEAT TESTED ON DIFFERENT ANALYZERS (INSTRUMENT TYPES NOT PROVIDED) THAT GENERATED INFLUENZA B NEGATIVE. NO PATIENT DETAILS WERE MADE AVAILABLE, AND NO HARM OR INJURY WAS INDICATED. PATIENTS¿ SAMPLES WERE COLLECTED USING NASOPHARYNGEAL SWAB COLLECTED USING THE GENE EXPERT MEDIA TUBE. THIS IS NOT A RECOMMENDED PRACTICE FOR SAMPLE COLLECTION. AS PER THE METHOD SHEET, COLLECT SPECIMEN USING A STERILE FLOCKED SWAB WITH A SYNTHETIC TIP ACCORDING TO APPLICABLE MANUFACTURER INSTRUCTIONS AND/OR STANDARD COLLECTION TECHNIQUE USING 3 ML OF VIRAL TRANSPORT MEDIA OR STERILE 0.9% PHYSIOLOGICAL SALINE. THE CUSTOMER CONFIRMED THERE WAS NO ALLEGATION OF HARM TO THE PATIENT. THE NEGATIVE RESULTS WERE REPORTED OUT TO THE PATIENTS AND/OR PERSONNEL TREATING THE PATIENTS. THIRTEEN (13) MDRS WILL BE FILED ONE FOR EACH SAMPLE AS PER FDA GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323530 COBAS LIAT SARS-COV-2 & INFLUENZA A/B FOR USE ON THE COBAS LIAT SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 10601T

    Patients

    Seq Age Sex Outcome Treatment
    1